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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640116

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640116 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640024

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640024 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640017

Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640017 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Alinity m - 00884999048034

Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

m2000 - 00884999031814

m2000rt Instrument System
ABBOTT MOLECULAR INC.
9K15-01
In Commercial Distribution

  • 00884999031814 ()
9K15-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas Liat Cleaning Tool - 00875197005660

No Description
Roche Molecular Systems, Inc.
07402759190
In Commercial Distribution

  • 00875197005660 ()
07402759190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FILMARRAY® COMMERCIAL LAPTOP - 00851458005297

FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
BIOFIRE DEFENSE, LLC
COMP-SUB-0034
In Commercial Distribution

  • 00851458005297 ()
COMP-SUB-0034

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FilmArray® 2.0 Instrument NGDS Configuration - 00851458005143

NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FilmArray® 2.0 Instrument NGDS Configuration - 00851458005129

Refurbished IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005129 ()
NGDS-ASY-0002U

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FILMARRAY - 00851458005112

NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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